Regional Implementation of Collaborative Lung Function Testing

Telehealth Clinical Trial

— e-Spiro-HC3  

Official title:

Regional Implementation of Collaborative Lung Function Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592928
• Other study ID #: 2015-PDMAR
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2019
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background/Aims There is evidence indicating that deployment of forced spirometry (FS) testing in a collaborative scenario, encompassing respiratory specialists and community professionals, generates healthcare efficiencies. The study describes the roadmap for regional implementation of the FS program in Catalonia (ES), from January to December 2016.

Methods/Design Firstly, the FS program will be deployed in three healthcare sectors (514 k inhabitants), following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for evaluation purposes. Thereafter, regional deployment of the FS program (7.5M inhabitants) will be conducted. The third step considers: evaluation of transferability, preparation for data analytics and recommendations for long-term assessment of outcomes. Main components of the FS program are: i) Automatic quality testing; ii) Standardized data transfer to a shared electronic health record; iii) Elaboration of individual FS reports including historical results; and, iv) Clinical decision support systems providing access to the FS report, and to remote support upon request.

Discussion/Conclusions The project constitutes the first attempt to scale-up a collaborative scenario for FS testing that will open new avenues for longitudinal lung function assessment. Moreover, the setting shows high potential for transferability to different sites and to other diagnostic procedures.

Description:

The Forced Spirometry program emerges from a series of studies reporting on technological solutions for each of the main components indicating the potential of their articulated application aiming at covering unmet needs for collaborative FS testing. The studies were initiated within the EU project NEXES22;23 and specific parts of the overall setting have already been successfully evaluated in the Basque Country.

The setting & Study design The current protocol has been designed as part of the regional deployment of integrated care services in Catalonia. It consists of the two lines of activity ultimately aiming at: i) regional adoption of the FS program; and, ii) generalization of the approach to other areas, as well as to other testing procedures. The research was submitted and apoved by the Ethical Committee of the Hospital Clínic i Provincial de Barcelona.

Program deployment The initial 6 months will include three healthcare sectors: Lleida (168k inhabitants and 21 Primary Care centers), Vic (49k inhabitants and 11 PCC), and Atenció Integral en Salut Barcelona Esquerra (AISBE) (540k inhabitants and 19 PCC) following a Plan-Do-Study-Act (PDSA) methodology24. The first PDSA cycle (January - March 2016) including a total of three primary care centers, one in each healthcare sector, has as main purpose to ensure full functionality of the setting. Immediately thereafter, the FS program will be progressively deployed to all Primary Care centers in the three sectors in a second 3-months PDSA cycle that will be completed by mid-2016. Forced spirometry testing will be prescribed by the attending general practitioner following standard criteria and it will be carried out by primary care nurses.

The deployment of the program in the entire region (7.5M inhabitants and 369 Primary Care centers) will be completed with no discontinuation within 2016. It will follow identical PDSA methodology. The outcomes of the assessment carried out during each PDSA cycle will modulate the long-term assessment strategy of the FS program described below.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients included in the regular practice

Exclusion Criteria:

• Clinical an Medical exclusion criteria as the forced spirometry standards recommend.

Related Conditions & MeSH terms

• Health Care Rationing
• Integrated Care
• Telehealth

Intervention

Other:
• Inclusion of Spirometry into the Electronic Health Records
Inclusion of the Forced Spirometry into the Electronic Health Records

Locations

Country	Name	City	State
Spain	Felip Burgos	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Department of Health, Generalitat de Catalunya, Eurecat, Fundació TicSalut, Institut Catala de Salut, Universitat Politècnica de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Burgos F, Disdier C, de Santamaria EL, Galdiz B, Roger N, Rivera ML, Hervàs R, Durán-Tauleria E, Garcia-Aymerich J, Roca J; e-Spir@p Group. Telemedicine enhances quality of forced spirometry in primary care. Eur Respir J. 2012 Jun;39(6):1313-8. doi: 10.1183/09031936.00168010. Epub 2011 Nov 10. — View Citation

Burgos F, Melia U, Vallverdú M, Velickovski F, Lluch-Ariet M, Caminal P, Roca J. Clinical decision support system to enhance quality control of spirometry using information and communication technologies. JMIR Med Inform. 2014 Oct 21;2(2):e29. doi: 10.2196/medinform.3179. — View Citation

Cano I, Alonso A, Hernandez C, Burgos F, Barberan-Garcia A, Roldan J, Roca J. An adaptive case management system to support integrated care services: Lessons learned from the NEXES project. J Biomed Inform. 2015 Jun;55:11-22. doi: 10.1016/j.jbi.2015.02.011. Epub 2015 Mar 18. — View Citation

Llauger MA, Rosas A, Burgos F, Torrente E, Tresserras R, Escarrabill J; en nombre del grupo de trabajo de espirometría del Plan Director de las Enfermedades del Aparato Respiratorio (PDMAR). [Accesibility and use of spirometry in primary care centers in Catalonia]. Aten Primaria. 2014 Jun-Jul;46(6):298-306. doi: 10.1016/j.aprim.2013.12.012. Epub 2014 Apr 24. Spanish. — View Citation

Melia U, Burgos F, Vallverdú M, Velickovski F, Lluch-Ariet M, Roca J, Caminal P. Algorithm for automatic forced spirometry quality assessment: technological developments. PLoS One. 2014 Dec 31;9(12):e116238. doi: 10.1371/journal.pone.0116238. eCollection 2014. — View Citation

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. — View Citation

Salas T, Rubies C, Gallego C, Muñoz P, Burgos F, Escarrabill J. Technical requirements of spirometers in the strategy for guaranteeing the access to quality spirometry. Arch Bronconeumol. 2011 Sep;47(9):466-9. doi: 10.1016/j.arbres.2011.06.005. Epub 2011 Aug 6. English, Spanish. — View Citation

Vargas C, Burgos F, Cano I, Blanco I, Caminal P, Escarrabill J, Gallego C, Llauger MA, Miralles F, Solans O, Vallverdú M, Velickovski F, Roca J. Protocol for regional implementation of collaborative lung function testing. NPJ Prim Care Respir Med. 2016 Jun 2;26:16024. doi: 10.1038/npjpcrm.2016.24. — View Citation

Velickovski F, Ceccaroni L, Roca J, Burgos F, Galdiz JB, Marina N, Lluch-Ariet M. Clinical Decision Support Systems (CDSS) for preventive management of COPD patients. J Transl Med. 2014 Nov 28;12 Suppl 2:S9. doi: 10.1186/1479-5876-12-S2-S9. Epub 2014 Nov 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Primary Care Centers (PCC) and professionals involved in the territory using the Electronic Health Records (EHR)	Number of PCC exporting both the raw spirometric data, including all FS curves, and the FS report to the shared electronic health record at a regional level.	Thought study completition in average of 18 months
Primary	Number of professionals using Forced Spirometry included in the EHR (percentage per PCC)	Number of professionals with accessi of the FS testing report, irrespective of the healthcare provider and health level wherein testing was performed	Thought study completition in average of 18 months
Primary	Change between inicial and end of the project (number of FS test included in the EHR)		Thought study completition in average of 18 months
Secondary	Forced Spirometry Parameters	- Measured in liters	Thought study completition in average of 18 months
Secondary	Grade of quality in relation of total Forced Spirometry	Percentage of patients with FS grade of quality (A-B-C-D-F) in relation of total FS	Thought study completition in average of 18 months
Secondary	Change from baseline in relations with ascertainment of COPD or Asthma diagnosis	Percentage of patients with FEV1/FVC ratio < 0.7 and without diagnosis of Asthma and COPD; Percentage of patients with FEV1/FVC ratio > 0.7 and with diagnosis Asthma and COPD; Percentage of patients with restrictive pattern and FEV1/FVC ratio < 0.7	Thought study completition in average of 18 months
Secondary	Number of participants per PCC	Long-term benefits from data analytics of longitudinal information; Assessments using unique measurements	Through study completion, an average of 18 months
Secondary	Grade of satisfaction about new servicies	Grade of satisfaction about new servicies (0-10)	Through study completion, an average of 18 months
Secondary	Rating the degree of clinical impact to obtain the historical spirometry values of each patient.	Rating the degree of clinical impact to obtain the historical spirometry values of each patient. Grade 0 -10	Through study completion, an average of 18 months
Secondary	Number of avoided duplication tests using the EHR	Number of avoided duplication tests using the EHR. measured as % of the total FS	Through study completion, an average of 18 months
Secondary	Cost-effectiveness (Rating usability and speed of data transfer)	Rating usability and speed of data transfer in minutes .	Through study completion, an average of 18 months
Secondary	Cost-effectiveness (reducing the time of access to information and better display of the information)	Questionnaire about reducing the time of access to information and better display of the information (measured in minutes).	Through study completion, an average of 18 months